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Associate Director, Global Trial Lead

0-2 years
USD 148,320 – 222,480
10 Dec. 18, 2025
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Global Trial Lead | Remote / Home-Based (Global)

Job ID: R14705
Category: Development Operations / Clinical Trials
Job Type: Full-Time
Locations: Flexible / Remote – Global; office options in North America, Europe, Asia-Pacific


About Genmab

Genmab is a leading international biotechnology company committed to improving patient lives through innovative antibody therapeutics. For over 25 years, Genmab has developed next-generation antibody technology platforms, including bispecific T-cell engagers, antibody-drug conjugates, immune checkpoint modulators, and effector function-enhanced antibodies.

Headquartered in Copenhagen, Denmark, Genmab operates globally across North America, Europe, and Asia-Pacific. By 2030, the company aims to transform cancer treatment and serious diseases through its proprietary Knock-Your-Socks-Off (KYSO®) antibody medicines.

Learn more at www.genmab.com and follow Genmab on LinkedIn and X.


Role Overview

The Associate Director, Global Trial Lead (GTL) is responsible for the end-to-end delivery of clinical trials, from initial strategy through Clinical Study Report (CSR) completion. This role leads cross-functional Clinical Trial Teams (CTT), manages trial budgets, and aligns internal and external stakeholders to achieve trial objectives efficiently and to high-quality standards.

The GTL serves as the main coordinator for the trial team and may assume Clinical Trial Manager (CTM) responsibilities if a CTM is not assigned.


Key Responsibilities

Trial Leadership and Management

  • Lead cross-functional Clinical Trial Teams (CTT), including Medical, Biostatistics, Programming, and Data Management teams.

  • Manage operational trial teams including Start-up Specialists, Clinical Trial Associates (CTA), and CTMs.

  • Assign tasks, set goals, and ensure deadlines are met.

  • Make tactical decisions to align CTT activities with program objectives.

  • Provide regular progress updates, risk assessments, and escalations to leadership.

  • Review and approve trial documentation, including protocols, amendments, and manuals.

  • Oversee vendor selection, contracts, and trial-related agreements.

  • Coordinate country selection and responses to IEC/IRB comments.

  • Maintain trial integrity through protocol adherence and proactive issue resolution.

Budget, Planning, and Risk Management

  • Develop, manage, and monitor trial budgets.

  • Maintain integrated trial timelines from study outline to CSR delivery.

  • Develop patient recruitment projections and adjust strategies as needed.

  • Identify, monitor, and mitigate trial risks.

  • Oversee issue, action, and decision logs for effective risk management.

  • Support audits, inspections, and implement corrective and preventive actions (CAPAs).

Cross-Functional Collaboration

  • Partner with internal stakeholders, CROs, and external partners to drive alignment toward project goals.

  • Inform strategy and synopsis development in collaboration with Clinical Development Teams (CDTs).

  • Lead and participate in cross-functional working groups and process improvement initiatives.

  • Mentor and train team members on emerging clinical trial best practices.


Required Qualifications

  • Proven experience in global, complex, matrixed organizations.

  • Pharmaceutical industry experience with ICH-GCP knowledge and regulatory compliance expertise.

  • Oncology or therapeutic area-specific drug development experience across multiple phases.

  • Experience mentoring others and leading teams in a matrix leadership environment.

  • Strong knowledge of end-to-end trial planning, execution, and outsourcing/vendor management.

  • Excellent project management, budget management, and stakeholder engagement skills.

  • Effective communication, negotiation, and collaboration skills.

  • Experience managing multi-regional clinical trials and complex operations.


Preferred Qualifications

  • Proven track record in driving process improvements and efficient trial execution.

  • Strong understanding of regulatory submissions, audit readiness, and clinical trial systems.

  • Demonstrated ability to align diverse cross-functional teams toward trial objectives.


Compensation and Benefits (US-Based Candidates)

  • Base Salary Range: USD 148,320 – 222,480 annually, based on experience, qualifications, and location.

  • Eligibility for discretionary bonuses and long-term incentives.

  • Comprehensive health, dental, and vision coverage.

  • 401(k) plan with company match.

  • Paid vacation, sick leave, holidays, and discretionary parental leave.

  • Wellness, financial planning, and lifestyle support resources.


About You

  • Passionate about advancing innovative therapies for patients with cancer and serious diseases.

  • Detail-oriented, precise, and committed to excellence in trial delivery.

  • Collaborative leader capable of guiding cross-functional teams in dynamic, global environments.

  • Experienced in fast-growing, matrixed organizations and adaptable to evolving priorities.

  • Committed to compliance, quality, and ethical standards in clinical research.